Factors Determining the Prognosis in NSCLC Stage IV

NCT ID: NCT04306094

Last Updated: 2020-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

217 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2022-02-01

Brief Summary

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This study is a cohort study with patients with advanced NSCLC. Patients will answer questionnaires about symptoms and quality of life and will be submitted to physical and blood tests, and computer tomography. The aim of this study is to estimate prognostic factors predicting survival to 3 months in patients with advanced NSCLC.

Detailed Description

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Non-small-cell lung cancer (NSCLC) is currently the neoplasm leading in deaths worldwide and in Brazil. NSCLC has a high incidence, is usually diagnosed in advanced stages and has poor survival rates. The ability to refine the prognosis of a disease has implications at the time of diagnosis and decision about treatment. Clinical and laboratory factors are studied to evaluated the prognosis of diseases. Palliative Prognostic Score (PaP score), Karnofsky Performance Status Scale (KPS), Palliative Prognostic Index (PPI) are applied in patients with many types of solid tumors. The Charlson Score evaluates comorbidities and the attributed risk for presence it. Others predictors of prognostic are cachexia, quality of life, inflammatory factors, sarcopenia. There is a need to improve the ability to estimate the prognosis and to identify the factors responsible to low survival rates in patients with NSCLC diagnosed at advanced stage, also as a tool for a better treatment selection.

This is an observational and prospective study, including patients diagnosed with NSCLC and admitted in ICESP, staged as IV at admission, with no previous systemic treatment and classified as ECOG 2-4. Demographic data, presence of a caregiver, anthropometry, MRC dyspnea scale, KPS, Edmont Symptom Scale, Charlson's Comorbidity Score, PPI and PaP were evaluated in each patient. Evaluation of sarcopenia and cachexia with abdominal CT (Slice-O-Matic, v.5), arm circumference, handgrip strength test and quality of life using EORTC score QLQ C-30 and QLQ-CAX-24 were also evaluated. Significant prognostic factors will be selected by multivariate analysis in a training set estimated as 217 patients.

Conditions

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NSCLC Stage IV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Advanced stage IVa or IVb NSCLC patients histologically diagnosis.
* Eastern Cooperative Oncology Group Performance status 2 - 4
* Treatment-naive

Exclusion Criteria

* Initiate treatment before initiate
* psychiatric illnesses, except depression
* pregnant or breastfeeding women
* two concomitant neoplasms
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Ana Paula de Souza Borges

physician, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ana Paula de Souza Borges

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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ana p borges

Role: CONTACT

+5511969057406

Facility Contacts

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ana p borges

Role: primary

11969057406

References

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Cunha MT, de Souza Borges AP, Carvalho Jardim V, Fujita A, de Castro G Jr. Predicting survival in metastatic non-small cell lung cancer patients with poor ECOG-PS: A single-arm prospective study. Cancer Med. 2023 Feb;12(4):5099-5109. doi: 10.1002/cam4.5254. Epub 2022 Sep 26.

Reference Type DERIVED
PMID: 36161783 (View on PubMed)

Other Identifiers

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NP1105/17

Identifier Type: -

Identifier Source: org_study_id

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